Trial Review

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In adults with chronic hepatitis C infection, does treating the HCV infection with 12 weeks of a direct acting antiviral combination ("Vikera Pak") result in an improvement of endothelial function as measured by reactive hyperaemia peripheral arterial tonometry?

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Secondary ID [1]2874110

Nil known

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Universal Trial Number (UTN)

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Trial acronym

CHESS

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Hepatitis C virus infection2961160

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Endothelial function2961170

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Condition category

Condition code

Infection29637629637600

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Other infectious diseases

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Cardiovascular29637829637800

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Diseases of the vasculature and circulation including the lymphatic system

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Oral and Gastrointestinal29646029646000

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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Before and after study. All patients will be assessed at baseline, week 2 and week 4 on no HCV treatment. They will then receive 12 weeks of active treatment with the “Abbvie 3D regimen” which is as follows: paritaprevir/ritonavir/ombitasvir (150/100/25 mg once daily by mouth), dasabuvir (250 mg twice daily by mouth) and weight-based RBV dosed twice daily by mouth(1000 mg daily if body weight < 75 kg, 1200 mg daily if body weight >= 75 kg). Ribavirin will be given to GT1a patients but not to GT1b patients

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Intervention code [1]2927630

Treatment: Drugs

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Comparator / control treatment

N/A

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Control group

Uncontrolled

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Outcomes

Primary outcome [1]2960230

Change in RH-PAT index over 12 weeks of HCV treatment compared with a 4 week baseline period

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Open label before and after study.

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

N/A

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Masking / blinding

Open (masking not used)

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Who is / are masked / blinded?

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Intervention assignment

Single group

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Other design features

N/A

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Phase

Phase 4

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

The primary outcome measure is the change in RH-PAT index between weeks 0 and 12 of treatment compared with during the pre-treatment observational phase. The two periods will be compared using a mixed effects linear regression model, with the slope and intercept of the model-fitted RHPAT trend line from the treatment period compared with that from the baseline period.

Hepatitis C virus (HCV) leads to cirrhosis and/or hepatocellular carcinoma in 20-40% of those infected after 30 years. It is unclear whether the remaining 60-80% of those with HCV derive an objective physical health benefit from the treatment and cure of HCV infection. HCV infection appears to be associated with increased cardiovascular risk, however this is controversial, and it is unclear whether the mechanism is through HCV-induced metabolic syndrome and diabetes, or through chronic inflammation and endothelial dysfunction. The aim of this study if to determine feasibility of using RH-PAT to measure change in endothelial function over time during HCV treatment, to refine assumptions and to seek a signal of effect. These data will then be used to determine if a larger multicentre trial is justifiable and to inform its design.